UHR UH1-51-28Recalls & reported problems
Howmedica Osteonics Corp. · Bipolar Component · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327017137), received between Jul 1, 2019 and Jan 20, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Material Discolored1
Patient problems
- Joint Dislocation3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryFeb 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
BIPOLAR DISASSOCIATED FROM OMNIFIT EON STEM AND 28/+5 COCR HEAD DURING A POST OP DISLOCATION/REDUCTION. THE BIPOLAR AND 28/+5 COCR HEADS WERE EXPLANTED DURING REVISION SURGERY. "THE COCR HEAD DID NOT COME OFF STEM, IT WAS REMOVED IN TACT WITH STEM. THE STEM WAS NOT REVISED". "THE COCR LFIT HEAD WAS IMPACTED OFF THE STEM, STEM WAS NOT REVISED".
Patient problems: Joint Dislocation
MAUDE report 13423144 ↗InjuryJan 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A 51MM BIPOLAR, 28MM +0 C TAPER COCR HEAD, AND 9/132 OMNIFIT HFX PRESSFIT APPLICATION STEM WERE USED IN A HEMIARTHROPLASTY ON (B)(6) 2021. ON TUESDAY (B)(6) 2021 I WAS CONTACTED BY DR, WHO DID THE HEMI, INDICATING THE PATIENT DISLOCATED, AND WE WOULD BE REVISING THE CASE. A 51MM BIPOLAR, 28 +5 COCR C TAPER HEAD, AND 7/132 OMNIFIT EON CEMENTED STEM WAS IMPLANTED ON (B)(6) 2021, ALL IMPLANTS FROM THE PRIMARY HEMI WERE EXPLANTED.
Patient problems: Joint Dislocation
MAUDE report 13259150 ↗MalfunctionJul 1, 2019Material Discolored; Material Discolored
BLACK STAINING OF UHR HEAD. AS REPORTED, "NEED TO GET NEW UHR HEAD FROM STOCK IN OR 5 MIN".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8750764 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.